A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity
Amgen
Summary
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participants in the study will be males and females 18 to 65 years of age at the time of signing the informed consent with a body mass index (BMI) of 30.0 kg/m\^2 to 40.0 kg/m\^2 for Part A and BMI of 27.0 kg/m\^2 to 40.0 kg/m\^2 for Part B. * Females enrolled must be of non-childbearing potential. Exclusion Criteria: * History and/or clinical evidence of diabetes mellitus, including hemoglobin A1c ≥ 6.5% and/or a fasting glucose of ≥ 126 mg/dL (7 mmol/L) at screening. * Triglycerides ≥ 5.65 mmol/L (i.e., 500 mg/dL) at screening.
Interventions
- DrugAMG 513
AMG 513 will be administered by SC or IV injection.
- DrugPlacebo
Placebo will be administered by SC or IV injection.
- DrugAMG 513
AMG 513 will be administered by SC injection.
- DrugPlacebo
Placebo will be administered by SC injection.
Locations (5)
- Anaheim Clinical TrialsAnaheim, California
- Carilion Medical CenterLake Forest, California
- Fomat Medical ResearchOxnard, California
- Translational Clinical Research LLCAventura, Florida
- Clinical Pharmacology of Miami, LLCMiami, Florida